Digital health products hold great promise to transform healthcare but need to return to the roots of evidence-best medicine to reach their full potential.
A new breed of disruptive digital health products is entering the market, claiming to be better, cheaper and easier to use than traditional alternatives. Digital technologies are rapidly revolutionizing the healthcare ecosystem, allowing patients and physicians to interact anytime, anywhere.
This movement, alongside a favorable economic climate and available capital, has created a brave new world of digital health companies and products with tremendous promise to improve patient care in altogether new ways.
But there are challenges to this. The evidence underlying the marketing claims of many of these digital health products is sparse. Healthcare purchasers are looking to select products that will bring the most value to their organizations and patient populations, but digital health companies don’t always clearly demonstrate the clinical or economic benefit of their product. This lack of data can lead to partially informed decision-making or inaction, both of which may ultimately hamper long-term growth of the digital health sector.
When I joined the medical technology industry in the late ‘90s, evidence-based medicine seemed to be a key topic of conversation at every major cardiovascular conference in the U.S. and Europe. The clinical value of new products and guidelines for their use were expected to be defined by controlled trial results. Post-market studies (i.e., those conducted once a product has been launched into the commercial market) in real-world clinical settings, beyond what was required for regulatory approval, generally became an unwritten requirement for broad adoption by the physician or payer communities. More recently, demand for economic evidence has increased, in part due to the Affordable Care Act’s acceleration of value-based care.
“Product value” in healthcare now sits squarely at the intersection of clinical validity (Does it actually work?), clinical utility (Is it actually used in the real-world to improve care?), and economic utility (Is it used in a way that leads to cost benefit?).
I think we can all agree that digital health products with real value can withstand the challenge of a clinical study or two…or three. So perhaps it is time for us all to go back to the future and learn a lesson from the late 20th century about the importance of evidence-based medicine — and recognize the need to adopt an evidence-based approach to digital health as a rule, and not the exception.
The best part of the solution set is that the healthcare ecosystem already knows the recipe for enabling evidence-based medicine, assuming that applicable regulatory clearance and approvals are attainable. You first need partnerships between the companies delivering the products and the healthcare systems that will adopt them. Next, you conduct studies to generate clinical and health economic evidence in those systems to prove product value, while establishing access to provider distribution channels for commercialization and integration into a new standard of care.
Essential to this recipe in the digital health era are a few key ingredients, such as clinical and economic outcomes research capabilities alongside predictive analytics that facilitate and validate precision digital medicine on a broad scale.
My company, Evidation Health, seeks to bring many of these elements together through a new approach to validating and optimizing digital medicine. We apply expertise in health outcomes research and product commercialization with behavioral and predictive analytics to help the best management strategies be deployed for the right patients at the right time.
It has been said that healthcare is a team sport, as the system is unlikely to be dramatically transformed by one entity alone. Evidation Health is committed to doing its part to realize a shared vision for an evidence-based, digital health-enabled future. As Thomas Edison advised, “There is a way to do it better – let’s find it.”
(Top image: Courtesy of Thinkstock)
Deborah Kilpatrick, PhD, is the CEO of Evidation Health, a digital health company backed by GE Ventures, Asset Management Ventures and Rock Health.